In this subtitle the following words have the meanings indicated. “Cholesterol testing” includes collecting a test specimen, testing to detect the amount of cholesterol in an individual’s blood, and the reporting of test results. “Permit” means a permit issued by the Secretary to a person who: Offers to provide, with or without charge, a test to detect the amount of cholesterol in an individual’s blood; and Conducts the test outside a permanently located medical laboratory issued a permit or excepted from a permit under Subtitle 2 of this title.

Except as provided under subsection (b) of this section and § 17-503 of this subtitle, a person shall obtain a permit from the Department before: Offering to provide a test to detect the amount of cholesterol in an individual’s blood; and Conducting the cholesterol test outside a permanently located medical laboratory issued a permit or excepted from a permit under Subtitle 2 of this title. A cholesterol testing permit is not required under this subtitle for a medical laboratory that: Is licensed under Subtitle 2 of this title; and As set forth in the license, provides tests or services in the discipline of chemistry or health awareness.

Any local or county health department may submit to the Secretary its cholesterol testing plan for review. The Secretary shall review all submissions under this section as soon as reasonably possible after the submission in order to determine whether it meets the standards necessary for adequate off-site cholesterol testing in accordance with this subtitle. If a plan submitted under this section meets the standards of this subtitle, the Secretary may waive the permit requirements of the subtitle and permit the submitting local or county health department to conduct cholesterol testing under this subtitle for a period of 12 months, provided that: The submission adequately describes the cholesterol testing plan for the effective 12 months; The local or county health department provides all information that the Secretary may reasonably require to determine compliance with this section; The local or county health department agrees to make records available and submit reports to the Secretary as the Secretary may require; Changes and amendments to the plan are submitted 60 days prior to proposed implementation; and All changes and amendments to the plan are approved by the Secretary. If a plan submitted under this section does not meet the standards of this subtitle, or if the information supplied in the submission is considered by the Secretary to be insufficient for a determination, the submitting local or county health department shall apply for a permit in accordance with this subtitle. The Secretary may cancel a waiver granted under this section at any time if the Secretary finds that the local or county health department does not continue to meet the standards of this subtitle.

The Secretary shall adopt regulations to implement the provisions of this subtitle, including regulations that assure the citizens of this State that cholesterol testing conducted outside a permanently located medical laboratory meets appropriate national standards of quality assurance. The regulations shall include: Personnel training standards, including requirements for reasonable training, experience, and competency in: Simple procedures used in drawing blood for cholesterol testing; and The operation of blood chemical analyzers used for cholesterol screening; Quality assurance standards; Standards for counseling and referral procedures; Standards for releasing and reporting test results; and A prohibition on the payment of any sum to any person for bringing or referring a patient. The Secretary may not require that cholesterol testing personnel that conduct cholesterol tests under this subtitle be certified in a medical laboratory specialty. All cholesterol testing conducted under this subtitle shall be overseen by a supervisor knowledgeable in all aspects of cholesterol testing services.

To qualify for a permit, an applicant shall meet the requirements of this subtitle and any regulation that the Secretary adopts under this subtitle.

An applicant for a permit shall submit an application to the Secretary on the form that the Secretary requires.

The Secretary shall issue a permit to any applicant who meets the requirements of this subtitle. The Secretary shall include on each permit: The name of the permittee; The address of the permittee; and The expiration date of the permit.

The Secretary may deny a permit to an applicant or suspend or revoke an existing permit for failure to comply with the provisions of this subtitle and any regulation adopted under this subtitle. Except as otherwise provided in the Administrative Procedure Act, before the Secretary takes any action under this section, the Secretary shall give the applicant or permit holder notice and an opportunity for a hearing.

Except as otherwise provided in this title, a person may not offer cholesterol testing in this State unless the person holds a permit from the Secretary. The permit is not transferable.

A person who violates any provision of this subtitle is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $100 for the first offense and not exceeding $500 for each subsequent conviction for a violation of the same provision. Each day a violation is continued after the first conviction is a subsequent offense.